Testing HRS-6208 for patients with advanced solid tumors
Official title: A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6208 Monotherapy in Patients With Advanced Solid Tumors
Run by Shandong Suncadia Medicine Co., Ltd. · NCT06727812 · Data updated 2026-11-12
This study is testing a new treatment called HRS-6208 to see if it is safe and helps people with advanced solid tumors that can't be treated with standard options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 206 (estimated) |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Status | Recruiting |
| Started | December 17, 2024 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | December 18, 2025 |
| Trial ID | NCT06727812 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with advanced solid tumors that are not amenable to surgery and have progressed after standard treatments.
✕Probably not a fit
Patients with a history of other malignancies within the past 5 years or those with severe cardiovascular or cerebrovascular diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open, multicenter Phase I study aims to evaluate the safety and tolerability of HRS-6208 in patients suffering from advanced solid tumors. The trial will enroll patients who have unresectable locally advanced or metastatic solid tumors that have either relapsed after standard treatments or have no available standard treatment options. Participants will be monitored for adverse effects and overall response to the treatment. The study will follow strict eligibility criteria to ensure the safety of participants.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have gone: While this approach is part of ongoing research in cancer treatment, the specific use of HRS-6208 in this context is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage; 2. Age 18\~75 years old; 3. At least one measurable lesion per RECIST v1.1 criteria; 4. ECOG PS score: 0-1. Exclusion Criteria: 1. History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1; 3. He has severe cardiovascular and cerebrovascular diseases; 4. Severe infection within 4 weeks prior to the first dose.
Where it's running
-
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China Recruiting -
West China Hospital of Sichuan University
Chengdu, Sichuan, China Recruiting
Study contacts
- Study coordinator: Xin Xu
- Email: xin.xu@hengrui.com
- Phone: 0518-82342973
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.